Hepatitis BNCT04998838
Stop Hep B @ Birth
A study testing Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG) and Regular Myanmar treatment in people with Hepatitis B, run by Myanmar Liver Foundation at 1 site in Burma.
Trial summary
Single arm, prospective open-label study of a care model consisting of two components: Component I aims to achieve high coverage of interventions to prevent maternal-to-child transmission of hepatitis B virus: antenatal tenofovir, and timely newborn administration of hepatitis B birth dose vaccine and hepatitis B… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG) and Regular Myanmar treatment
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteBurma
- Study dates
- 1 Jul 2018to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women >= 18 years of age
- Gestational age =<34 weeks
- Test positive for HBsAg
- Live in study site area in South Dagon and Dagon Seikkan Townships, Yangon Region
- Give informed consent to participate in the study
- Newborns and household members of pregnant women enrolled in the study according to previous inclusion criteria
Show all 17Show fewer
- Key informants (e.g., healthcare providers and community leaders in the study area) OR
- HBsAg+ women and their household members in the study area
- HBsAg- women and their household members in the stud area
- Give informed consent to participate in the study
- History of renal dysfunction
- CrCL < 50mL/min
- ALT>5 times the upper limit of normal (ULN)
- Evidence of decompensated cirrhosis (e.g., jaundice, ascites, history of upper gastrointestinal bleeding/esophageal varices, and hepatic encephalopathy)
- Any concomitant condition or treatment that, in view of the clinical site investigator, would contraindicate participation or satisfactory follow-up in the study HIV positive status unless 1) they are currently on additional ART therapy, or 2) their viral load is demonstrated to be <50 copies. Women who are newly diagnosed with HIV and referred to start a TDF-based regimen may be considered eligible once they have started the TDF-based regimen.
- Concurrent participation in any other clinical trial without written agreement of the study team
- Does not intend to deliver within catchment area, and/or intends to migrate before newborn follow-up is complete
Who cannot join
- Alanine aminotransferase (ALT) levels >300 IU/L
- For qualitative study:
Trial locations and contacts
1 site in 1 country.
Burma1 site, 1 recruiting
- Recruiting
BK Kee Clinic
Yangon
Hnin Nandar Htut, nandar@bkkeefoundation.org
About this study
Official title: Stop Hep B @ Birth: Community-Oriented Care Model for the Prevention of Mother-To-Child Transmission of Hepatitis B in Peri-Urban Yangon
Single arm, prospective open-label study of a care model consisting of two components: Component I aims to achieve high coverage of interventions to prevent maternal-to-child transmission of hepatitis B virus: antenatal tenofovir, and timely newborn administration of hepatitis B birth dose vaccine and hepatitis B immune globulin; Component II aims to achieve high coverage of screening, vaccination, and anti-viral therapy for HBV among household members of women with chronic HBV infection.
Read the detailed description
An estimated 248 million people worldwide are chronically infected with hepatitis B virus (HBV); and 75% of them live in Asia. Mother-to-child transmission (MTCT) accounts for the majority of chronic hepatitis B infections in Southeast Asia. Elimination of MTCT of HBV is theoretically possible with a comprehensive suite of interventions that includes birth dose vaccination, hepatitis B immune globulin, and antenatal antiviral therapy (e.g., tenofovir). However, the ideal gestational age to initiate antenatal tenofovir remains undefined; and evidence is lacking for implementation strategies capable of providing cost-effective, equitable access to a comprehensive suite of interventions to prevent MTCT of HBV in low-resource settings.
Component I: Prevention of Vertical Transmission Pregnant women living in the study area will be identified and screened for hepatitis B by a network of antenatal care (ANC) providers and existing community outreach workers; HBsAg positive patients will be invited to participate in the study. Consenting participants will provide serum samples to assess eligibility for anti-viral therapy: creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelet count, HCV, HIV. Pregnant women eligible for antiviral therapy according to WHO criteria, or who have viral load (VL) >200,000 IU/mL, will be treated with tenofovir starting at 20 weeks gestation through 4 weeks postpartum. Hospital-based delivery will be encouraged. All newborns, including those delivered at home, will receive the HBV birth dose vaccine within 24 hours of delivery, and newborns of women on tenofovir treatment will also receive Hepatitis B Immunoglobulin within 24 hours after delivery. Children will be linked to routine immunization services in Myanmar to complete their HBV vaccination series (HBV is co-formulated in a pentavalent vaccine). Maternal VL will be measured at delivery; infants will be tested for hepatitis B infection at 24-28 weeks postpartum.
Component II -- Household Screening and Treatment The household members of HBsAg positive pregnant women who consent to participate in the study will be screened for HBV-related immune status and chronic HBV infection. Non-immune individuals (HBsAb/Ag negative) will be vaccinated; HBsAg positive household members will be assessed for treatment eligibility and initiated on anti-viral therapy according to World Helath Organization guidelines. Eligible household members will also be screened every six months for hepatocellular carcinoma (HCC) by liver ulatrasound and alpha-fetoprotein levels
Qualitative Study:
In-depth interviews with approximately 30 HBsAg-positive women, 30 HBVsAg-negative women, and 20 household members of study participants will be conducted to assess barriers and facilitators related to HBV testing and treatment. Approximately 15 key-informant interviews with healthcare providers and community leaders will also be conducted. Sample size will depend on data saturation and will be adjusted based on results of data analysis during the study.
- Conditions
- Hepatitis B
- Being tested
- Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG), Regular Myanmar treatment
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG)Drug
Also called Viread
Antenatal screening for HBV, anti-viral treatment with tenofovir according to treatment eligibility criteria, and birth dose vaccination at delivery to prevent mother-to-child transmission of HBV
Regular Myanmar treatmentDrug
Treated according to normal Myanmar processes for HBV positive patients
| Study group | Role | What they receive |
|---|---|---|
| Tenofovir Disoproxil Fumerate | Experimental | Pregnant women (\>=20 weeks of gestation) will be treated with TDF if clinically eligible; newborns will receive birth dose vaccine (and HBIG if eligible). Non-eligible women will be treated according to normal practices; newborns will still receive birth dose vaccine. Receives: Drug: Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG); Drug: Regular Myanmar treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine within 24 hours
Proportion of newborns of HBsAg positive mothers receiving HBV vaccine within 24 hours of birth
Measured: Within 24 hours of birth
Effective treatment of pregnant women
Proportions of pregnant women with chronic HBV (HBsAg positive) who are (a) linked to care (attend BK Kee Clinic for assessment of treatment eligibility); (b) complete TDF eligibility testing; (c) initiate tenofovir treatment (TDF, among those eligible); (d) adhere to TDF treatment until delivery and (e) continue treatment until 4 weeks post-partum
- Low/medium/high high medication adherence are defined, respectively, as ≤6, 6-7 or 8 points on the Morisky Medication Adherence Scale (MMAS-8)
Measured: During pregnancy (until delivery) of each woman, average of 9 months
Household contact screening
Proportions of adult household contacts who (a) are screened for chronic HBV infection and immunity (HBsAg/Ab); (b) are linked to care (among HBsAg positive) or vaccinated (if HBsAb negative); (c) complete appropriate testing for hepatocellular carcinoma (HCC) screening, (d) eligible for TDF treatment; (e) initiate chronic HBV treatment with TDF
Measured: Upon identification of participating women, until the end of the project, average of 1 year
Secondary outcomes (7)
Total screening of mothers
Proportion of pregnant women in the target population who are:
- screened for HBsAg (denominator estimated from population census counts and crude birth rate)
- HBsAg positive (chronic HBV prevalence among women attending ANC)
Measured: During pregnancy (until delivery) of each woman, average of 9 months
Antenatal care for HBV positive pregnant mothers
Proportions of pregnant women with chronic HBV who:
- attend their first antenatal care (ANC) visit prior to 20, 24, 28 and 32 weeks gestation
- are eligible for TDF (HBV VL >200,00 IU/mL or WHO criteria)
- are HBeAg positive
- deliver at home
Measured: During pregnancy (until delivery) of each woman, average of 9 months
Vaccination of HBV negative pregnant mothers
Proportion of women who tested negative for HBsAg and HBsAb at baseline who complete the HBV vaccination schedule
Measured: During pregnancy (until delivery) of each woman, average of 9 months
Treatment of high viral load pregnant mothers
Among women who had VL>200,000 IU/mL at baseline and were eligible for TDF treatment:
- the proportion that achieve viral suppression (HBV DNA <200,000 IU/mL) at delivery
- the proportion who are HBeAg positive
- proportion with HBV flare 4 months postpartum (ALT >300 IU/L)
Measured: At delivery; during antenatal care testing; at 4 months postpartum, throughout the project, average of 12 months
Viral suppression
Associations of maternal viral suppression (VL <200,000 at delivery and: baseline HBV VL, duration of exposure to TDF, and TDF adherence
Measured: At delivery, throughout the project (one off)
Mother-to-child transmission
Proportion of infants born to HBsAg positive mothers who
- complete the HBV vaccination series within the recommended intervals
- are HBsAg positive or with measurable HBV VL at 28 weeks postpartum (rate of mother-to-child transmission of HBV)
Measured: At 28 weeks postpartum, throughout the project (one off)
Household screening
Among household members screened for HBsAg and HBsAb:
- Prevalence of chronic infection (% HBsAg positive); and immune status (% HBsAb positive and HBsAg negative)
Measured: At household screening, throughout the project (one off)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2021
- Study start1 Jul 2018
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Antenatal screening for HBV, anti-viral treatment with tenofovir according to treatment eligibility criteria, and birth dose vaccination at delivery to prevent mother-to-child transmission of HBV
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myanmar Liver Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khin Pyone Kyi, Myanmar Liver Foundation
- Investigators
- Khin Phone Kyi, MD, Principal investigator, Myanmar Liver FoundationAdam K Richards, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04998838
- Sponsor's protocol ID
- HBV2020
- Status last verified
- Aug 2021
- First submitted
- 19 Jan 2021
- Last updated
- 10 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators are currently developing an individual participant data (IPD) sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Hep B @ Birth: Community-Oriented Care Model for the Prevention of Mother-To-Child Transmission of Hepatitis B in Peri-Urban Yangon
- ClinicalTrials.gov ID
- NCT04998838
- Acronym / sponsor ID
- HBV2020
- Conditions
- Hepatitis B
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Myanmar Liver FoundationUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 10 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Single arm, prospective open-label study of a care model consisting of two components: Component I aims to achieve high coverage of interventions to prevent maternal-to-child transmission of hepatitis B virus: antenatal tenofovir, and timely newborn administration of hepatitis B birth dose vaccine and hepatitis B immune globulin; Component II aims to achieve high coverage of screening, vaccination, and anti-viral therapy for HBV among household members of women with chronic HBV infection.
Detailed description
An estimated 248 million people worldwide are chronically infected with hepatitis B virus (HBV); and 75% of them live in Asia. Mother-to-child transmission (MTCT) accounts for the majority of chronic hepatitis B infections in Southeast Asia. Elimination of MTCT of HBV is theoretically possible with a comprehensive suite of interventions that includes birth dose vaccination, hepatitis B immune globulin, and antenatal antiviral therapy (e.g., tenofovir). However, the ideal gestational age to initiate antenatal tenofovir remains undefined; and evidence is lacking for implementation strategies capable of providing cost-effective, equitable access to a comprehensive suite of interventions to prevent MTCT of HBV in low-resource settings.
Component I: Prevention of Vertical Transmission Pregnant women living in the study area will be identified and screened for hepatitis B by a network of antenatal care (ANC) providers and existing community outreach workers; HBsAg positive patients will be invited to participate in the study. Consenting participants will provide serum samples to assess eligibility for anti-viral therapy: creatinine, aspartate aminotransferase (AST), alanine aminotransferase (ALT), platelet count, HCV, HIV. Pregnant women eligible for antiviral therapy according to WHO criteria, or who have viral load (VL) >200,000 IU/mL, will be treated with tenofovir starting at 20 weeks gestation through 4 weeks postpartum. Hospital-based delivery will be encouraged. All newborns, including those delivered at home, will receive the HBV birth dose vaccine within 24 hours of delivery, and newborns of women on tenofovir treatment will also receive Hepatitis B Immunoglobulin within 24 hours after delivery. Children will be linked to routine immunization services in Myanmar to complete their HBV vaccination series (HBV is co-formulated in a pentavalent vaccine). Maternal VL will be measured at delivery; infants will be tested for hepatitis B infection at 24-28 weeks postpartum.
Component II -- Household Screening and Treatment The household members of HBsAg positive pregnant women who consent to participate in the study will be screened for HBV-related immune status and chronic HBV infection. Non-immune individuals (HBsAb/Ag negative) will be vaccinated; HBsAg positive household members will be assessed for treatment eligibility and initiated on anti-viral therapy according to World Helath Organization guidelines. Eligible household members will also be screened every six months for hepatocellular carcinoma (HCC) by liver ulatrasound and alpha-fetoprotein levels
Qualitative Study:
In-depth interviews with approximately 30 HBsAg-positive women, 30 HBVsAg-negative women, and 20 household members of study participants will be conducted to assess barriers and facilitators related to HBV testing and treatment. Approximately 15 key-informant interviews with healthcare providers and community leaders will also be conducted. Sample size will depend on data saturation and will be adjusted based on results of data analysis during the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Antenatal screening for HBV, anti-viral treatment with tenofovir according to treatment eligibility criteria, and birth dose vaccination at delivery to prevent mother-to-child transmission of HBV
| Arm | Type | Receives |
|---|---|---|
| Tenofovir Disoproxil Fumerate | Experimental | Drug: Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG), Drug: Regular Myanmar treatmentPregnant women (\>=20 weeks of gestation) will be treated with TDF if clinically eligible; newborns will receive birth dose vaccine (and HBIG if eligible). Non-eligible women will be treated according to normal practices; newborns will still receive birth dose vaccine. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (17 listed)
- Pregnant women >= 18 years of age
- Gestational age =<34 weeks
- Test positive for HBsAg
- Live in study site area in South Dagon and Dagon Seikkan Townships, Yangon Region
- Give informed consent to participate in the study
Key exclusion criteria (2 listed)
- Alanine aminotransferase (ALT) levels >300 IU/L
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG)Also: VireadAntenatal screening for HBV, anti-viral treatment with tenofovir according to treatment eligibility criteria, and birth dose vaccination at delivery to prevent mother-to-child transmission of HBV | Drug | Tenofovir Disoproxil Fumerate |
| Regular Myanmar treatmentTreated according to normal Myanmar processes for HBV positive patients | Drug | Tenofovir Disoproxil Fumerate |
Primary outcome
Vaccine within 24 hours
Time frame: Within 24 hours of birth
Proportion of newborns of HBsAg positive mothers receiving HBV vaccine within 24 hours of birth
Effective treatment of pregnant women
Time frame: During pregnancy (until delivery) of each woman, average of 9 months
Proportions of pregnant women with chronic HBV (HBsAg positive) who are (a) linked to care (attend BK Kee Clinic for assessment of treatment eligibility); (b) complete TDF eligibility testing; (c) initiate tenofovir treatment (TDF, among those eligible); (d) adhere to TDF treatment until delivery and (e) continue treatment until 4 weeks post-partum o Low/medium/high high medication adherence are defined, respectively, as ≤6, 6-7 or 8 points on the Morisky Medication Adherence Scale (MMAS-8)
Household contact screening
Time frame: Upon identification of participating women, until the end of the project, average of 1 year
Proportions of adult household contacts who (a) are screened for chronic HBV infection and immunity (HBsAg/Ab); (b) are linked to care (among HBsAg positive) or vaccinated (if HBsAb negative); (c) complete appropriate testing for hepatocellular carcinoma (HCC) screening, (d) eligible for TDF treatment; (e) initiate chronic HBV treatment with TDF
7 secondary outcomes
Total screening of mothers
Time frame: During pregnancy (until delivery) of each woman, average of 9 months
Antenatal care for HBV positive pregnant mothers
Time frame: During pregnancy (until delivery) of each woman, average of 9 months
Vaccination of HBV negative pregnant mothers
Time frame: During pregnancy (until delivery) of each woman, average of 9 months
Treatment of high viral load pregnant mothers
Time frame: At delivery; during antenatal care testing; at 4 months postpartum, throughout the project, average of 12 months
Viral suppression
Time frame: At delivery, throughout the project (one off)
Mother-to-child transmission
Time frame: At 28 weeks postpartum, throughout the project (one off)
Household screening
Time frame: At household screening, throughout the project (one off)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Individual participant dataSharing planned: Undecided. The investigators are currently developing an individual participant data (IPD) sharing plan.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khin Phone Kyi, MD principal investigator
Myanmar Liver Foundation
Adam K Richards, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG) and Regular Myanmar treatment in people with Hepatitis B, run by Myanmar Liver Foundation at 1 site in Burma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burma. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khin Pyone Kyi, MD (+95 9 250 022 398, pmcthbv2018kpk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaccine within 24 hours (time frame: Within 24 hours of birth). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.